FDA 510(k)

Innova 鼻腔非通风口罩

K号: K203601 · 2021-04-30

决定日期2021-04-30

产品代码BZD

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决定实质等同

器械摘要

Innova Nasal Non-Vented Mask is the device name listed in this FDA 510(k) record. The listed applicant is Sleepnet Corporation. It received FDA 510(k) clearance on 2021-04-30 under 510(k) number K203601. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Innova Nasal Non-Vented Mask?

Innova Nasal Non-Vented Mask is a medical device that received FDA 510(k) clearance on 2021-04-30. The listed applicant is Sleepnet Corporation. The 510(k) number is K203601.

When did Innova Nasal Non-Vented Mask receive FDA 510(k) clearance?

Innova Nasal Non-Vented Mask received FDA 510(k) clearance on 2021-04-30, under 510(k) number K203601.

Who is the listed applicant for Innova Nasal Non-Vented Mask?

The FDA 510(k) record lists Sleepnet Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Innova Nasal Non-Vented Mask?

The FDA product code for Innova Nasal Non-Vented Mask is BZD.

列明Sleepnet Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K251847Sleepnet Arie 全脸通风口罩；Sleepnet Arie 鼻通风口罩 K241830Mojo 全脸通风口罩；Veraseal 2 全脸通风口罩；Innova 全脸通风口罩；Ascend 全脸通风口罩 K241943Mojo 全脸非通风口罩；Veraseal 2 全脸非通风口罩；Veraseal 2 全脸 AAV 非通风口罩 K241661Mojo 2 全脸通风口罩；Veraseal 3 全脸通风口罩；V3 全脸通风口罩 K241520Mojo 2 全脸非通风口罩；Mojo 2 全脸 AAV 非通风口罩；Veraseal 3 全脸非通风口罩；Veraseal 3 全脸 AAV 非通风 K241469iQ 2 鼻部通气口罩；幻影 2 鼻部通气口罩

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